Key Responsibilities Lead new product introductions (NPI) and support the scale-up of manufacturing processes. Take ownership of tooling and plastic molding , ensuring robust verification and validation of components to support repeatable production. Manage global supply chain operations including procurement, supplier performance, inventory, and logistics. Oversee validation of new equipment , including documentation in line with quality and regulatory requirements. Ensure compliance with ISO 13485 and support the creation of regulatory documentation as needed. Coordinate production, inventory control, and distribution planning. Manage change control processes (ECRs/ECNs), maintain technical documentation, and ensure quality compliance. Work closely with suppliers to reduce lead times and improve operational efficiency. Collaborate with Sales, Marketing, and Finance to support product launches, customer audits, and cross-functional initiatives. Provide regular updates on operational KPIs and project performance. What You Bring A degree in Engineering, Supply Chain, Business , or a related field. 5 years’ experience in operations, process engineering, or supply chain managementideally in a regulated industry . Proven experience in tooling, plastic moulding , and hands-on process development. Strong knowledge of manufacturing, logistics, and inventory systems . Experience with ERP systems , Excel (PivotTables), MS Project, and other planning tools. Strong communication, collaboration, and problem-solving skills. Comfortable working in a fast-paced, evolving environment . Willingness to travel to engage with suppliers and partners as needed. Bonus Points For Familiarity with medical device regulations and documentation. Experience with Lean, Six Sigma, or Kaizen continuous improvement methodologies. Working knowledge of ISO 13485 and validation protocols in a regulated environment.

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